Methodology Study on Bacterial Endotoxin Test of Four Antioxidants Used in Injections

OBJECTIVE To establish the quality standard for the bacterial endotoxins test of four antioxidants(anhydrous sodium sulfite,sodium bisulfite,sodium pyrosulfite and sodium thiosulfate).METHODS The test was operated according to the method for examination of bacterial endotoxin test in Ch.P(2005)Vol II.RESULTS The four antioxidants did not interfere with TAL reagent under the concentration of 200 μg·mL-1.The appropriate limit of endotoxin was 2.5 EU·mg-1.CONCLUSION It was feasible to use this method in the examination of the four antioxidants.